CRED Managing Variations Effectively

Risk analysis: B.II.b.1 new manufacturing site

+ Grouped with B.II.b.3 Manufacturing change(s)

Magnitude : Will problem be serious ?

High

Medium

Low

High

Sodium valproate tablets Digoxin

Hydrocortisone cream

Cyclizine injection

Medium Etoposide tablets Simvastatin tablets Low Phenobarbital solution Aciclovir tablet

Amoxicillin tablets

Ibuprofen tablets

Atenolol syrup Amitriptyline oral soln Otex ear drops Pholcodeine linctus

162

Is problem likely?